Trial · NCT01846299
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye | Baseline, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement. |
| Secondary | Change From Baseline in BCVA in Study Eye up to Month 2 | Baseline, Month 1, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement. |
| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFV was assessed OCT. A negative change from baseline indicates improvement. |
| Secondary | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Month 6, Month 12 | The presence of intra-retinal fluid was assessed by OCT. |
| Secondary | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Month 6, Month 12 | The presence of subretinal fluid was assessed by OCT. |
| Secondary | Number of Participants With Presence of Active Macular Edema (ME) Leakage | Month 2 | The presence of active ME leakage was assessed by fluorescein angiography (FA). |
| Secondary | Number of Participants Requiring Rescue Treatment at Month 1 | Month 1 | Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of \> 5 letters due to disease activity from baseline to Month 1. |
| Secondary | Average Change From Baseline in BCVA | Baseline (BL), month 1 through month 6, month 1 through month 12 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement. |
| Secondary | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Month 6 , Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
| Secondary | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Month 6, Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
| Secondary | Number of Participants With Ranibizumab Treatments | Month 12 | The number of participants administered study treatments, according to treatment frequency, was assessed. |
| Secondary | Number of Participants With Re-treatments | Month 6, month 12 | The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to Month 12, the maximum number of retreatments was 5. |
| Secondary | Number of Primary Reasons for Decision to Treat by Investigator | 12 months | The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01846299/registered